American Society of Clinical Oncology, June 1-5, 2012

The annual meeting of the American Society of Clinical Oncology was held from June 1 to 5 in Chicago and attracted approximately 20,000 participants from around the world, including clinicians, academicians, allied health professionals, and others interested in oncology. The conference featured the latest advances in clinical cancer research, with presentations focusing on novel targeted therapies as well as improvements in chemotherapy and radiation therapy approaches.

In a phase II study, Brian Rini, M.D., of the Cleveland Clinic, and colleagues evaluated dose escalation of axitinib in the first-line setting for the treatment of patients with metastatic renal cell carcinoma.

"Among 213 patients, we found that progression-free survival was 14.5 months, longer than other treatments for renal carcinoma, and the objective response rate was greater than 40 percent," Rini said. "Overall, we found that axitinib demonstrated efficacy in the first-line setting. While the results of this study will not change the label approval, they shed further insight into the use of axitinib in the first-line setting."

In a poster presentation focusing on a trial in progress, Michael Boyer, M.D., of the Sydney Cancer Centre in Australia, and colleagues presented a study outline on a trial evaluating the efficacy and safety of dacomitinib, an irreversible pan-HER inhibitor. Dacomitinib binds covalently to epidermal growth factor receptor (EGFR) (HER 1), HER 2 and HER 4, potentially leading to more complete inhibition of the HER pathways, as compared to single receptor (EGFR) inhibitors. The investigators are evaluating the efficacy and safety of dacomitinib in the phase III ARCHER 1009 study in patients with non-small-cell lung cancer of all histological types who have progressed after one or two previous chemotherapy regimens.

"Patients in this study are randomized to treatment with either dacomitinib or the approved EGFR tyrosine kinase inhibitor erlotinib. Importantly, all patients must have tumor tissue available for mutation testing. It builds on the results of the randomized phase II study described above, which showed improved progression-free survival for patients receiving dacomitinib compared to those treated with erlotinib," Boyer said. "Because that study showed an even bigger advantage for those patients whose tumors were KRAS wild-type, ARCHER is looking at progression-free survival in all patients, but with a co-primary population of patients with KRAS wild-type tumors. At present, about 320 patients out of a planned total of 800 have been enrolled."

The ARCHER trial is being funded by Pfizer; several authors disclosed financial ties to pharmaceutical companies, including Pfizer.

In a phase III study, George Demetri, M.D., of the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues found that regorafenib improved outcomes for patients with gastrointestinal stromal tumors (GIST) that were resistant to imatinib and sunitinib.

The investigators randomized 199 patients with metastatic and/or inoperable GIST who had previously undergone treatment with imatinib and sunitinib to regorafenib or placebo plus best supportive care. The investigators found that progression-free survival was significantly improved in those who received regorafenib. Eight-five percent of patients who worsened on placebo were allowed to switch to regorafenib treatment.

"If approved, regorafenib will fulfill an urgent, unmet need for patients with GIST who have exhausted all other treatment options," Demetri said in a statement. "Targeted therapy has revolutionized treatment for this rare cancer, but we've been on the hunt for additional effective treatments for the 85 percent of patients whose cancer eventually develops resistance to the only two available therapies. Regorafenib appears to target GIST tumors in a different and possibly more powerful way than the current U.S. Food and Drug Administration-approved therapies, making it a potentially significant new option to help patients."

Several authors disclosed financial ties to pharmaceutical companies, including Bayer, which developed regorafenib.

In a phase III study, Eric Larsen, M.D., of the Maine Medical Center Cancer Institute in Portland, and colleagues found that adolescents and young adults between the ages of 15 and 30 years with high-risk acute lymphoblastic leukemia had worse outcomes as compared to toddlers and adolescents between the ages of 1 and 15 years. The investigators evaluated event-free survival and overall survival in these patient populations.

"This study tells us that the inferior outcome for adolescent and young adult patients is the result of more resistant disease, resulting in higher rates of relapse and higher toxicity from treatment," Larsen said in a statement. "We have to find novel agents to better eradicate the leukemia, but, while we want to intensify therapy, we also have to reduce toxicity."

In two clinical trials evaluating patient reported outcomes among patients with metastatic renal cell carcinoma, David Cella, Ph.D., of the Northwestern University Feinberg School of Medicine in Chicago, and colleagues provided insight into fatigue associated with sunitinib (Sutent).

In study one, 375 patients were randomized to sunitinib 50 mg/day, dosed on a four-weeks-on/two-weeks-off (4/2) schedule for up to 30 cycles. In study two, 292 patients were randomized to sunitinib 50 mg/day, dosed on a 4/2 schedule or on a 37.5 mg continuous daily schedule.

"In study one, patients reported notable fatigue in cycle 1, which improved or stabilized, thereafter. In study two, schedule 4/2 was associated with more within-cycle fluctuation in fatigue," the authors write. "These findings illustrate how Sutent-associated fatigue occurs early in therapy and continues with more within-cycle fluctuation associated with 4/2 dosing. This may help patient-clinician communications and interventions that support maintaining effective therapy."

Several authors disclosed financial ties to Pfizer, which manufactures sunitinib; one author also disclosed financial ties to AVEO, GlaxoSmithKline, and Novartis.

TUESDAY, June 5 (HealthDay News) -- Continuing use of bevacizumab (Avastin) in combination with second-line chemotherapy improves overall survival (OS) and progression-free survival (PFS) in patients with metastatic colorectal cancer (mCRC) who have progressed after discontinuation of first-line bevacizumab and chemotherapy, according to the results of a phase III study presented at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

MONDAY, June 4 (HealthDay News) -- For patients with metastatic melanoma with activating mutations in serine-threonine protein kinase B-RAF (BRAF), treatment with the oral selective MEK inhibitor trametinib is associated with improved progression-free and overall survival, compared with chemotherapy, according to a study published online June 4 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

MONDAY, June 4 (HealthDay News) -- Trastuzumab emtansine (T-DM1) significantly improves progression-free survival (PFS) compared to treatment with capecitabine (Xeloda) and lapatinib (Tykerb) (referred to as XL) in women with HER2-positive (HER2+) locally advanced or metastatic breast cancer (MBC), according to a study being presented at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

MONDAY, June 4 (HealthDay News) -- The anti-programmed death (PD)-1 monoclonal antibody BMS-936558 is active in patients with melanoma, non-small-cell lung cancer (NSCLC), and renal cell cancer that has progressed despite standard therapy, according to a study published online June 2 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

MONDAY, June 4 (HealthDay News) -- For women with platinum-resistant ovarian cancer, the addition of bevacizumab (Avastin) to chemotherapy is associated with improved progression-free survival, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

FRIDAY, May 18 (HealthDay News) -- For pediatric patients with tumors that have genetic aberrations in the anaplastic lymphoma kinase (ALK) gene, crizotinib is well tolerated and has antitumor activity, according to a study released May 16 in advance of presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

FRIDAY, May 18 (HealthDay News) -- Most oncologists can identify the main late or long-term effects (LEs) of chemotherapy drugs, but primary care physicians (PCPs) are less likely to be able to do so, according to a study released May 16 in advance of presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

THURSDAY, May 17 (HealthDay News) -- For men with localized high-risk prostate cancer, neoadjuvant androgen deprivation therapy with abiraterone acetate (AA) plus leuprolide acetate (LHRHa) is well tolerated and has good pathological complete/near complete response (pCR/near pCR) rates, according to a study released May 16 in advance of presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

THURSDAY, May 17 (HealthDay News) -- For patients with V600 BRAF-mutant solid tumors, treatment with the oral BRAF inhibitor dabrafenib and the oral MEK 1/2 inhibitor trametinib is tolerated and has clinical activity in BRAF inhibitor-naive metastatic melanoma, according to a study released May 16 in advance of presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.

THURSDAY, May 17 (HealthDay News) -- For patients receiving highly emetogenic chemotherapy who experience breakthrough chemotherapy-induced nausea and vomiting, treatment with olanzapine (Zyprexa) is significantly better than treatment with metoclopramide, according to a phase III study released May 16 in advance of presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.